Lymph Node Radiation Therapy in Patients With Stage I, Stage II, or Stage III Breast Cancer That Has Been Surgically Removed
- Conditions
- Breast Cancer
- Registration Number
- NCT00002851
- Brief Summary
RATIONALE: Radiation therapy may kill any tumor cells remaining after surgery.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to no further therapy in treating women with stage I, stage II, or stage III breast cancer that has been surgically removed.
- Detailed Description
OBJECTIVES:
* Compare the effect of irradiation of the homolateral internal mammary and medial supraclavicular lymph node chains vs no further therapy on survival, disease-free survival, metastasis-free survival, and cause of death in women with resected stage I/II/III breast cancer.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating institution, tumor location, type of prior breast surgery, pathologic T and N stage, menopausal status, and time sequence of radiotherapy and adjuvant chemotherapy. Patients are randomized to 1 of 2 arms.
* Arm I: Patients receive no nodal irradiation.
* Arm II: Patients receive irradiation of the internal mammary and medial supraclavicular lymph node chains delivered at 1 fraction per day, 5 sessions per week, for a total of 25 fractions over 5 weeks. Radiotherapy must begin no later than 8 weeks after surgery. If adjuvant chemotherapy is given, radiotherapy begins within 6 weeks after the last course of chemotherapy and within 8 months after surgery.
Patients are followed at least yearly after randomization for up to 20 years.
PROJECTED ACCRUAL: A total of 4,000 patients will be accrued for this study within 4 years.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 4000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (48)
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
Radiotherapeutisch Instituut Limburg-Maastricht
🇳🇱Maastricht, Netherlands
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
🇫🇷Dijon, France
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Centre Hospitalier Universitaire Henri Mondor
🇫🇷Strasbourg, France
Institute of Oncology - Clinical Center University of Sarajevo
🇧🇦Sarajevo, Bosnia and Herzegovina
Hopital de Jolimont
🇧🇪Haine Saint Paul, Belgium
Cazk Groeninghe - Campus Maria's Voorzienigheid
🇧🇪Kortrijk, Belgium
Instituto de Radiomedicina
🇨🇱Santiago, Chile
Clinica Alemana
🇨🇱Santiago, Chile
CHR de Besancon - Hopital Jean Minjoz
🇫🇷Besancon, France
Institut Bergonie
🇫🇷Bordeaux, France
Service Cancerologie Polyclinique Clairval
🇫🇷Marseille, France
CHU de Grenoble - Hopital de la Tronche
🇫🇷Grenoble, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Centre Eugene Marquis
🇫🇷Rennes, France
Centre Paul Strauss
🇫🇷Strasbourg, France
Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
🇩🇪Berlin, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Centre Leon Berard
🇫🇷Strasbourg, France
Institut Gustave Roussy
🇫🇷Strasbourg, France
Charite - Campus Charite Mitte
🇩🇪Berlin, Germany
Klinik I fuer Innere Medizin
🇩🇪Cologne, Germany
University of Erlangen-Nuremberg
🇩🇪Erlangen, Germany
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
Ospedale Sant Anna
🇮🇹Como, Italy
Istituto Nazionale per la Ricerca sul Cancro
🇮🇹Genoa (Genova), Italy
Universitaetsklinikum Goettingen
🇩🇪Goettingen, Germany
Rambam Medical Center
🇮🇱Haifa, Israel
Chaim Sheba Medical Center
🇮🇱Ramat-Gan, Israel
Academisch Ziekenhuis Groningen
🇳🇱Groningen, Netherlands
Streekziekenhuis Gooi-Noord
🇳🇱Blaricum, Netherlands
Medisch Centrum Haaglanden
🇳🇱's-Gravenhage (Den Haag, the Hague), Netherlands
Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands
Radiotherapeutisch Instituut-(Riso)
🇳🇱Deventer, Netherlands
Medical University of Gdansk
🇵🇱Gdansk, Poland
Dr. Bernard Verbeeten Instituut
🇳🇱Tilburg, Netherlands
Academisch Ziekenhuis Utrecht
🇳🇱Utrecht, Netherlands
Istanbul University-Institute of Oncology
🇹🇷Istanbul, Turkey
Hopital Cantonal Universitaire de Geneve
🇨ðŸ‡Geneva, Switzerland
UniversitaetsSpital
🇨ðŸ‡Zurich, Switzerland
Institut Catala D'Oncologia
🇪🇸Barcelona, Spain
Nottingham City Hospital NHS Trust
🇬🇧Nottingham, England, United Kingdom
Centre Hospitalier Universitaire Vaudois
🇨ðŸ‡Lausanne, Switzerland
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Instituto Portugues de Oncologia Centro do Porto, SA
🇵🇹Porto, Portugal
Ziekenhuis Network Antwerpen Middelheim
🇧🇪Antwerp, Belgium
Algemeen Ziekenhuis Sint-Augustinus
🇧🇪Wilrijk, Belgium